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Could a simple ketone drink slow ALS? new trial results are in

NCT ID NCT04820478

Disease control Sponsor: University of Ulm Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a daily ketone supplement (beta hydroxybutyrate ester) in 81 people with ALS to see if it could slow the disease. The idea is that ketones provide extra energy to cells, which may help counter the energy shortage seen in ALS. Participants took the supplement alongside their usual medication, and researchers measured changes in blood markers and physical function over six months.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

81 people

The number who actually took part.

Started

Apr 2022

Finished

Feb 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Probable (clinically or laboratory) or definite ALS according to the revised version of the El Escorial World Federation of Neurology criteria * loss of Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R) of ≥ 0.33 points per month since onset (first paresis), based on the formula: (48 - score at screening visit) / (months between onset and screening visit) * age ≥ 18 years * continuously treated with 100 mg riluzole per day for at least 4 weeks * capable of thoroughly understanding all information given and giving full informed consent according to good clinical practice (GCP) Exclusion Criteria: * hyperinsulinism * pyruvate decarboxylase deficit * disturbance of fatty acid oxidation * disturbance of gluconeogenesis * acute porphyria * metabolism disorders which prevent utilization or degradation of ketone bodies * severe gastro-esophageal reflux * renal insufficiency (medical history and/or elevated serum creatinine levels and/or glomerular filtration rate (GFR) \<90 ml/min * previous participation in another interventional study within the preceding 4 weeks * tracheostomy * pregnancy or breast-feeding females * evidence of a major psychiatric disorder or clinically evident dementia * intake of diuretics * severe dysphagia * nutrition via percutaneous endoscopic gastrostomy (PEG) * electrolyte or acid-base imbalance * heart failure New York Heart Association (NYHA) II or above

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Conditions

The condition(s) this trial relates to.

amyotrophic lateral sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amyotrophic lateral sclerosis

Contacts and locations

Locations

  • University of Ulm

    Ulm, Baden-Wurttemberg, 89081, Germany

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Other studies related to the condition(s) this trial covers.